NCT03532932

A Study to Evaluate Disease Control and Treatment Pattern in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD) in Real Life Practice

International, Multicentre, Non-Interventional Study To Evaluate Disease Control And Treatment Pattern In Patients With Moderate To Severe Inflammatory Bowel Disease In Real Life Practice

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,990 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to characterize the treatment patterns associated with biologics agents use or non-biological therapy in participants with moderate to severe Ulcerative Colitis (UC) and Crohn's Disease (CD).

Detailed description

This is a non-interventional, retrospective and prospective study of participants with IBD. This study will collect data to provide accurate and comprehensive information related to treatment patterns associated with biologics use or non-biological therapy in participants with moderate to severe UC and CD in routine clinical practice. The study will have retrospective data collection from past records of participants within the last 2 years before participant's enrollment. The prospective part of the study will include one year of observation and data collection after the participant's enrollment in the study. The study will enroll approximately 2000 participants. Participants will be enrolled in one of the two groups: * UC Participants * CD Participants This multi-center trial will be conducted in Russia, Belarus and Kazakhstan. The overall period of observation in this study will be approximately 12 months. Participants will make 2 visits within their routine practice to the clinic after the enrollment into the study including a final visit at Month 12.

Conditions

• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Diseases

Timeline

• Start date: 2018-07-20
• Primary completion: 2021-11-08
• Completion: 2021-11-08
• First posted: 2018-05-22
• Last updated: 2024-03-29
• Results posted: 2024-03-29

Locations

36 sites across 3 countries: Belarus, Kazakhstan, Russia